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Study to Define Safety and Effectiveness of Dolutegravir (DTG) Use in Human Immunodeficiency Virus (HIV) Positive Pregnant Women

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ClinicalTrials.gov Identifier: NCT03564613
Recruitment Status : Active, not recruiting
First Posted : June 21, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
The purpose of this study is to assess the safety and effectiveness of DTG use in HIV positive pregnant women. This is a 3-year multi-site prospective observational study. Approximately, 250 HIV positive pregnant women from potential European AIDS Treatment Network (NEAT ID) sites across Europe will be enrolled. The enrollment period will be over 2 years with a follow-up period of 1 year for outcomes. The data collected will be that obtained during routine standard of care assessments; and the subjects will not undergo any interventional study procedures.

Condition or disease Intervention/treatment
HIV Infections Drug: DTG

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DOLOMITE NEAT ID Network Study: A Prospective, Multi-site Observational Study to Define the Safety and Effectiveness of Dolutegravir Use in HIV Positive Pregnant Women
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : September 18, 2019
Estimated Study Completion Date : April 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
HIV positive pregnant women
Data from approximately 250 HIV positive pregnant women with exposure to DTG from potential investigational sites across Europe will be included.
Drug: DTG
Subjects with DTG exposure during any trimester will be included




Primary Outcome Measures :
  1. Number of female subjects with spontaneous abortion [ Time Frame: Up to 1 year ]
    Spontaneous abortion is defined as death of a fetus or expulsion of the products of conception before 22 weeks gestation.

  2. Number of female subjects with induced abortion [ Time Frame: Up to 1 year ]
    Induced abortion is defined as voluntary termination of pregnancy before 22 weeks gestation.

  3. Number of female subjects giving still births [ Time Frame: Up to 1 year ]
    Still birth is defined as the death of a fetus occurring at 22 weeks of gestation or more, or for situations in which the gestational age is unavailable, a fetus weighing at least 500 grams.

  4. Number of female subjects with multiple births [ Time Frame: Up to 1 year ]
    Number of female subjects giving multiple births will be reported.

  5. Number of female subjects with type of deliveries [ Time Frame: Up to 1 year ]
    The different type of deliveries will be summarized.

  6. Maternal viral load (VL) at delivery [ Time Frame: Up to 1 year ]
    The maternal viral load at the time of delivery will be summarized.

  7. Number of infants with birth defects [ Time Frame: Up to 1 year ]
    Birth defects will be classified according to World Health Organization's International Classification of Diseases, Tenth Revision.

  8. Gestational age [ Time Frame: Up to 1 year ]
    Number of females with birth collected data for gestational age as a measure of birth defects will be reported.

  9. Birth weight [ Time Frame: Up to 1 year ]
    Number of females with birth collected data for birth weight as a measure of birth defects will be reported.

  10. Number of female subjects giving premature births [ Time Frame: Up to 1 year ]
    Premature birth is defined as birth of live infant at <32 weeks gestation

  11. Number of female subjects giving live births [ Time Frame: Up to 1 year ]
    Number of female subjects giving live births will be reported.

  12. Infants with low birth weight [ Time Frame: Up to 1 year ]
    Low birth weight is defined as birth weight of <2500 grams.

  13. Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score in infants [ Time Frame: Up to 1 year ]
    APGAR score in infants as a measure of birth defects will be calculated.

  14. HIV status of Infants [ Time Frame: Up to 1 year ]
    Infant's HIV status as a measure of birth defects will be reported.


Secondary Outcome Measures :
  1. Number of female subjects with drug related Adverse Events and Serious Adverse Events [ Time Frame: Up to 1 year ]
    Number of females with all drug related Adverse Events and Serious Adverse Events will be reported. These will be categorized by trimester of initiation.

  2. Rate of DTG discontinuation in pregnant women [ Time Frame: Up to 1 year ]
    Number of pregnant females with discontinuation of DTG will be reported.

  3. Number of participants who discontinued DTG [ Time Frame: Up to 1 year ]
    Reasons for DTG discontinuation will be summarized. Number of participants who discontinued DTG will be reported.

  4. Number of participants with VL at discontinuation [ Time Frame: Up to 1 year ]
    VL at discontinuation will be summarized to assess suppression. Number of participants with VL at discontinuation will be reported.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   HIV positive pregnant women
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Approximately, 250 HIV positive pregnant women having exposure to DTG from potential NEAT ID investigational sites across Europe will be enrolled.
Criteria

Inclusion Criteria:

  • HIV positive pregnant women aged 18 years and over on DTG
  • With no maternal or birth outcomes yet
  • Subjects are able and willing to provide written informed consent and comply with any safety reporting requirements.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564613


Locations
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United States, North Carolina
GSK Investigational Site
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
ViiV Healthcare
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare

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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT03564613     History of Changes
Other Study ID Numbers: 208759
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request Site
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ViiV Healthcare:
HIV
Dolutegravir
Europe
NEAT ID
pregnancy
Safety
Antiretroviral

Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Slow Virus Diseases
HIV Integrase Inhibitors
Anti-HIV Agents
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Immune System Diseases
Dolutegravir
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents